National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH
formerly NCCAM)

Special Note: Applicants are cautioned that not all
NIH Institutes and Centers (ICs) participate in this program, and that
consultation with relevant IC staff prior to submission of an application is
strongly encouraged. The participating ICs have different emphases and
program requirements for this program. Therefore, a prospective applicant is
urged to consult the Table of IC-Specific
Information, Requirements and Staff Contacts to determine whether
the planned research and training falls within the mission of one of the
participating NIH ICs.

Funding Opportunity Title

Ruth L. Kirschstein National Research
Service Awards for Individual Predoctoral Fellowships to Promote Diversity in
Health-Related Research (Parent F31 - Diversity)

February 18, 2014 - See Notice NOT-OD-14-060. Notice of Intent to Publish the Reissuance of this FOA.

October 19, 2012 - See Notice NOT-AT-13-002. The purpose of this Notice is to inform potential applicants to the Ruth L. Kirschstein National Research Service Awards listed below that effective immediately, NCCAM will not accept applications to these programs proposing to conduct new, free-standing clinical trials or studies.

December 14, 2011 - See Notice NOT-OD-12-022 Ruth L. Kirschstein National Research Service Awards (NRSA) and Other Fellowship Applications: New Policy on Post-Submission Information on Sponsor’s Research Funding .

June 30, 2011 - Per Notice NOT-AT-11-004, NCCAM will no longer participate in PA-11-111 (Parent F31). NCCAM will still participate in the Parent F31 - Diversity, Parent T32 and Parent T35 funding opportunities.

April 1, 2011 - This Notice is being provided to clarify instructions in Section IV. Application and Submission Information. See NOT-OD-11-062.

February 24, 2011 - See Notice NOT-OD-11-046 Reminder of Requirement for Certification Letter for Applications in Response to this FOA and Deadline for Their Receipt.

The purpose of this individual predoctoral research
training fellowship is to improve the diversity of the health-related
research workforce by supporting the training of predoctoral students from
groups that have been shown to be underrepresented. Such candidates include
individuals from underrepresented racial and ethnic groups, individuals with
disabilities, and individuals from disadvantaged backgrounds.

(Now Expired March 8, 2014 per issuance of PA-14-148), Originally May 8, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the Individual
Fellowship SF424 (R&R) Application Guide except where instructed to do
otherwise (in this FOA or in a Notice from the NIH Guide for Grants and
Contracts). Conformance to all requirements (both in the Application
Guide and the FOA) is required and strictly enforced. Applicants must read and
follow all application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

The overall goal of the NIH
Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly
trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and
clinical research needs. More
information about NRSA programs may be found at the Ruth L. Kirschstein
National Research Service Award (NRSA) website.

The
purpose of the F31 predoctoral fellowship to promote diversity in
health-related research is to provide up to five years of support for research
training leading to the PhD or equivalent research degree, the combined MD/PhD
degree (up to six years of support); or another formally combined professional
degree and research doctoral degree in biomedical, behavioral, health services,
or clinical sciences. These fellowships will enhance the diversity of the
biomedical, behavioral, health services, and clinical research labor force in
the United States by providing opportunities for academic institutions to
identify and recruit students from diverse population groups to seek graduate
degrees in health-related research and apply for this fellowship. The goal of
this program is to increase the number of scientists from diverse population
groups who are prepared to pursue careers in biomedical, behavioral, social,
clinical, or health services research.

The NIH recognizes a unique and compelling need to promote
diversity in the biomedical, behavioral and clinical sciences research
workforce. The NIH expects that efforts to diversify the workforce to lead to:

The recruitment of the most talented researchers from all
groups;

An improvement in the quality of the educational and
training environment;

A balanced perspective in setting research priorities;

An improved capacity to recruit subjects from diverse
backgrounds into clinical research protocols;

An improved capacity to address and eliminate health
disparities.

Accordingly, the NIH continues to encourage institutions to
diversify their student and faculty populations and thus to increase the
participation of individuals currently underrepresented in the biomedical,
clinical, behavioral, and social sciences. This announcement seeks to stimulate
the participation of individuals from the following groups:

A. Individuals from
underrepresented racial and ethnic groups;

B. individuals with
disabilities; and

C. individuals from
socially, culturally, economically, or educationally disadvantaged backgrounds
that have inhibited their ability to pursue a career in health-related
research.

See Section III for additional information regarding
eligibility for this program.

Special Note: Applicants are cautioned that not all
NIH Institutes and Centers (ICs) participate in this program, and that
consultation with relevant IC staff prior to submission of an application is
strongly encouraged. The participating ICs have different emphases and program
requirements for this program. Therefore, a prospective applicant is urged to
consult the Table of IC-Specific
Information, Requirements and Staff Contacts to determine whether
the planned research and training falls within the mission of one of the
participating NIH ICs.

Section II. Award Information

Funding Instrument

Grant

Application Types Allowed

New
Resubmission
Renewal: Individual fellowship awards are generally not
renewable. In rare cases in which fellowship awardees require further
fellowship support, they should consult with NIH staff to obtain advice regarding
submission of a renewal application.

The number of awards is contingent upon NIH
appropriations, and the submission of a sufficient number of meritorious
applications.

Award Budget

Award budgets are composed of stipends, tuition and fees,
and institutional allowance, as described below.

Award Project Period

Individuals may receive up to 5 years of aggregate
Kirschstein-NRSA support at the predoctoral level (up to 6 years for dual
degree training, e.g., MD/PhD), including any combination of support from institutional
training grants (e.g. T32) and an individual fellowship award. Fellowship
awards are often limited to 2-3 years.

Other Award Budget
Information

Stipends

Kirschstein-NRSA awards provide stipends as a subsistence
allowance to help defray living expenses during the research and clinical
training experiences.

The most recent stipend levels are described on the Kirschstein-NRSA
webpage. NIH will adjust awards on the anniversary date
of the award to ensure consistency with the stipend level in effect at that
time.

Before submitting a fellowship application, the applicant
fellow must identify a sponsoring institution. The sponsoring institution must
have staff and facilities available on site to provide a suitable environment
for performing high-quality research. The research training should occur in a
research-intensive environment that has appropriate human and technical
resources and is demonstrably committed to research training in the particular
program proposed by the applicant fellow. The sponsoring institution may be
private (profit or nonprofit) or public, including the NIH Intramural Programs
and other Federal laboratories.

An individual may request support for training abroad. In
such cases, the applicant fellow is required to provide detailed justification
for the foreign training, including the reasons why the facilities, the
sponsor, or other aspects of the proposed experience are more appropriate than
training in a domestic setting. The justification is evaluated in terms of the
scientific advantages of the foreign training as compared to the training
available domestically. Foreign training will be considered for funding only
when the scientific advantages are clear.

Required Registrations

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal
Investigator)

Any applicant fellow with the skills, knowledge, and
resources necessary to carry out the proposed research as the Project
Director/Principal Investigator (PD/PI) is invited to work with his/her sponsor
and organization to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.

Multiple Principal Investigators are not allowed.

By the time of award, the individual must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status).

For the purpose of this announcement, institutions are
encouraged to identify Fellowship Applicants who will increase diversity on a
national or institutional basis. As indicated in Section I, the NIH is
particularly interested in encouraging the recruitment and retention of the
following classes of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the report Women, Minorities, and Persons with Disabilities in Science and Engineering, 2007, p. 262). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution are eligible for support under this program.

B. Individuals with
disabilities, who are defined as those with a physical or mental impairment
that substantially limits one or more major life activities.

C. Individuals from
disadvantaged backgrounds, who are defined as:

Individuals who
come from a family with an annual income below established low-income
thresholds. These thresholds are based on family size; published by the U.S.
Bureau of the Census; adjusted annually for changes in the Consumer Price
Index; and adjusted by the Secretary for use in all health professions
programs. The Secretary periodically publishes these income levels at
http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income
backgrounds, the institution must be able to demonstrate that such candidates
have qualified for Federal disadvantaged assistance or they have received any
of the following student loans: Health Professions Student Loans (HPSL), Loans
for Disadvantaged Student Program, or they have received scholarships from the
U.S. Department of Health and Human Services under the Scholarship for
Individuals with Exceptional Financial Need.

Individuals who
come from a social, cultural, or educational environment such as that found in
certain rural or inner-city environments that have demonstrably and recently
directly inhibited the individual from obtaining the knowledge, skills, and
abilities necessary to develop and participate in a research career.

Eligibility related to a
disadvantaged background (C1 and C2) is most applicable to high school and
perhaps to undergraduate candidates, but would be more difficult to justify for
individuals beyond that level of academic achievement. Under extraordinary
circumstances the PHS may, at its discretion, consider an individual beyond the
undergraduate level to be from a disadvantaged background. Such decisions will
be made on a case-by-case basis, based on appropriate documentation.

Certification Letter

Applicants are required to attach a letter from the institution certifying eligibility of the Fellowship applicant for this program. The certification letter must be on institutional letterhead and scanned so that an institutional official signature is visible. See instructions in the SF424 Individual Fellowship Application Guide.

The applicant fellow must show evidence of both high
academic performance in the sciences and substantial interest in a research
area of high priority to the participating Institutes.

The applicant fellow must have a baccalaureate degree and be currently enrolled
in a PhD or equivalent research degree program (e.g., EngD, DNSc, Dr PH, DSW,
PharmD, PsyD, ScD), a formally combined MD/PhD program, or other combined
professional/clinical and research doctoral (e.g., DDS/PhD) in the biomedical,
behavioral, or clinical sciences at a domestic or foreign institution. The
Kirschstein-NRSA F31 may not be used to support studies leading to the MD, DDS,
or other clinical, health-professional training (e.g., DC, DMD, DNP, DO, DPM,
DVM, ND, OD, AuD).

Students seeking support for pursuit of a combined degree program (e.g. MD/PhD,
or DO/PhD, or DDS/PhD) also may be eligible to apply for the Kirschstein-NRSA
for Individual Predoctoral MD/PhD Fellows (F30).

NIH will not accept any application that is essentially the
same as one already reviewed. An individual may not have two or more competing
NIH fellowship applications pending review concurrently.

Duration of Support

Individuals may not exceed the aggregate limit of NRSA
support shown above in the Award Project Period.
Applicant fellows must consider any prior NRSA research training in determining
the duration of support requested. Information regarding previous
Kirschstein-NRSA support must be included in the application and will be
considered at the time of award.

Level of Effort

At the time of award, individuals are required to pursue
their research training on a full-time basis, normally defined as 40 hours per
week or as specified by the sponsoring institution in accordance with its own
policies.

Sponsor

Before submitting the application, the applicant fellow must
identify a sponsor (sometimes called a mentor) who will supervise the proposed
training and research experience. See Section IV below for more specific
requirements for the Sponsor and any co-sponsor(s).

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Fellowship Application Guide, except where instructed in this
funding opportunity announcement to do otherwise. Conformance to the
requirements in the Application Guide is required and strictly enforced.
Applications that are out of compliance with these instructions may be delayed
or not accepted for review.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
application submission. Follow the instructions in the SF 424 (R&R) to
determine which components are required.

Page Limitations

All page limitations described in the SF424 (R&R) Individual
Fellowship Application Guide and the Table of
Page Limits must be followed.

Other Project Information Component

All instructions in the SF424 (R&R) Individual
Fellowship Application Guide must be followed, with the following additional
instructions:

This attachment must include: (see updated instructions per NOT-OD-11-062)

Scores for all standardized exams such as MCAT, GRE, and other
relevant exams.

A listing of the applicant’s courses with grades from all
undergraduate and graduate institutions in which the applicant is/has been
enrolled must be included in the Fellowship Applicant Biographical Sketch
Format Page. Do not include transcripts with the application (applicants may be
asked to send transcripts prior to award).

A description of the graduate or combined degree program in which
the applicant is enrolled must be included in the application.

The filename provided for each “Other Attachment”
will be the name used for the bookmark in the electronic application in eRA
Commons.

PHS Fellowship Supplemental Form

All instructions in the SF424 (R&R) Individual
Fellowship Application Guide must be followed, with the following additional
instructions:

Research Strategy (Component of
Research Training Plan)

Applicant fellows must describe a tailored research
training plan, including a description of the research strategy (preferably
hypothesis-driven) well-suited to the stage of his/her career development.
Describe the skills and techniques that the applicant fellow will learn during
the award period, and discuss the relationship of the proposed research
training to the applicant fellow’s career goals. The applicant fellow must
describe the background leading to the proposed research, the significance of
the research, the research approach (design and methods) for achieving the
Specific Aims, the rationale, and expected/alternative outcomes of the proposed
studies. It is beneficial to include pertinent preliminary data obtained by the
applicant fellow in the current or prior laboratory.

Doctoral Dissertation and Other
Research Experience (Component of Additional Information)

The applicant fellow should discuss how the proposed
research training plan will add to the fellowship experience. Advanced graduate
students must include a narrative of their doctoral dissertation (may be
preliminary) and any other prior research experience. All graduate students
should include any applicable research experience. Please note that while the
instructions direct Predoctoral Fellows to omit this section, the information
is required of advanced graduate students who have successfully completed their
comprehensive examinations or the equivalent by the time of award and will be
performing dissertation research. All graduate students should include any
research experience, if applicable.

Sponsor(s)
and Co-Sponsor(s)

Before submitting a fellowship application, the
applicant must identify a sponsor (also called mentor or supervisor) who will
supervise the training and research experience. The sponsor should be an active
investigator in the area of the proposed research training and be committed
both to the research training of the Fellowship Applicant and to the direct
supervision the applicant’s research. The sponsor must document the
availability of sufficient research support and facilities for high-quality
research training. The sponsor, or a member of the mentoring team, should have
a successful track record of mentoring predoctoral students. Applicants are
encouraged to identify more than one mentor, i.e., a mentoring team, if this is
deemed advantageous for providing expert advice in all aspects of the research
and training program. In such cases, one individual must be identified as the
principal sponsor who will coordinate the applicant’s research training
program. The applicant must work with his/her sponsor(s) in preparing the
application.

The sponsor should describe the
research training plan for the applicant fellow (coordinated with the applicant
fellow’s research strategy). The sponsor and any co-sponsors are also expected
to provide an assessment of the applicant fellow’s qualifications and potential
for a research career. The research environment and the availability and
quality of needed research facilities and research resources (e.g., equipment,
laboratory space, computer time, available research support, etc.) must also be
described. The description should include items such as classes, seminars, and
opportunities for interaction with other groups and scientists. Training in
career skills, e.g. grant-writing and making effective presentations, is
strongly encouraged.

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, and Sharing
Model Organisms) as provided in the SF424 (R&R) Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

Letters of Reference

Applicant fellows must
carefully follow the SF424 (R&R) Individual Fellowship Application Guide,
including the time period for when letters of reference will be accepted. Applications lacking the required reference
letters may be delayed in review or not reviewed. Please note that the
specified Fellowship Reference Form must be used. This is a separate process from
submitting an application electronically. Reference letters are submitted
directly through the eRA Commons Referee Information link and not through Grants.gov. Note that the sponsor
and any co-sponsors may not submit a letter of reference.

Foreign Organizations

Foreign (non-US) organizations must follow policies
described in the NIH Grants
Policy Statement, and procedures for foreign organizations described
throughout the SF424 (R&R) Individual Fellowship Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement. The National
Research Service Award (NRSA) policies apply to this program. A
Kirschstein-NRSA fellowship may not be held concurrently with another federally
sponsored fellowship or similar Federal award that provides a stipend or
otherwise duplicates provisions of this award.

Pre-award costs are generally not allowable for Fellowships.

6. Other Submission
Requirements and Information

Applications must be submitted electronically following the
instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD/PIs must include their eRA Commons ID in the Credential
fieldof the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For this particular announcement, note the following:

Remember that the F programs are training awards and not research
awards. Major considerations in the review are the applicant fellow's potential
for a productive career, the applicant fellow's need for the proposed training,
and the degree to which the research training proposal, the sponsor, and the
environment will satisfy those needs.

Overall Impact/Merit

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood that the fellowship will enhance the
candidate’s potential for, and commitment to, a productive independent
scientific research career in a health-related field, in consideration of the
scored and additional review criteria.

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact.

Fellowship Applicant

Are the applicant fellow’s academic record and research
experience of high quality?

Does the applicant fellow have the potential to develop as
an independent and productive researcher in biomedical, behavioral or clinical
science?

Sponsors, Collaborators, and Consultants

Are the sponsor(s) research qualifications (including successful
competition for research support) and track record of mentoring appropriate for
the proposed fellowship?

Are there (1) evidence of a match between the research interests
of the applicant fellow and the sponsor (including an understanding of the
applicant’s research training needs) and (2) a demonstrated ability and
commitment of the sponsor to assist in meeting these needs?

Are the qualifications of any collaborator(s) and/or consultant(s),
including their complementary expertise and previous experience in fostering
the training of fellows, appropriate for the proposed research project?

Research Training Plan

Is the proposed research plan of high scientific quality, and
does it relate to the applicant fellow’s training plan?

Is the training plan consistent with the applicant fellow’s stage
of research development?

Will the research training plan provide the applicant fellow with
individualized and supervised experiences that will develop research skills
needed for his/her independent and productive research career?

Training Potential

Does the proposed research training plan have the potential to
provide the applicant fellow with the requisite individualized and supervised
experiences that will develop his/her research skills?

Does the proposed research training have the potential to serve
as a sound foundation that will lead the applicant fellow to an independent and
productive career?

Institutional Environment &
Commitment to Training

Are the research facilities, resources (e.g. equipment,
laboratory space, computer time, subject populations), and training
opportunities adequate and appropriate?

Is the institutional environment for the scientific development
of the applicant fellow of high quality, and is there appropriate institutional
commitment to fostering the applicant fellow’s training as an independent and
productive researcher?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not
involve one of the six categories of research that are exempt under 45 CFR Part
46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

Not Allowed.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Training in the Responsible Conduct
of Research

Taking into account the circumstances of the fellow,
including level of experience, the reviewers will address the following
questions. Does the plan satisfactorily address the format of instruction, e.g.
lectures, coursework, and/or real-time discussion groups? Do plans include a
sufficiently broad selection of subject matter, such as conflict of interest,
authorship, data management, human subjects and animal use, laboratory safety?
Do the plans adequately describe the role of the sponsor/mentor or other
faculty involvement in the fellow’s instruction? Does the plan meet the
minimum requirements for RCR, i.e., eight contact hours of instruction every
four years? Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE,
and the summary statement will provide the consensus of the review committee. Applications rated UNACCEPTABLE will not be funded until the applicant provides an acceptable, revised plan.
See also: NOT-OD-10-019.

Applications from Foreign Organizations

Reviewers will assess whether the project presents
special opportunities for furthering research programs through the use of
unusual talent, resources, populations, or environmental conditions that exist
in other countries and either are not readily available in the United States or
augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following
Resource Sharing Plans, or the rationale for not sharing the following types of
resources, are reasonable: 1) Data Sharing
Plan; and 2) Sharing
Model Organisms.

Budget and Period of Support

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

May undergo a committee process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications
will receive a second level of review by the appropriate NIH Institute or
Center. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as determined
by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Fellowships funded primarily for educational purposes are
exempted from the PHS invention requirements and thus invention reporting is
not required. More details, including exceptions for fellows training at NIH
are provided in the NIH Grants
Policy Statement.

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program. Accordingly, recipients are hereby notified that
they may be contacted after the completion of this award for periodic updates
on various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.

3. Reporting

When multiple years are involved, awardees will be required
to submit a Kirschstein-NRSA Individual Fellowship Progress Report for
Continuation Support (PHS 416-9)
annually. The report is due two months before the beginning date of the next
budget period and must include information describing the current year's
progress as well as the research and training plans for the coming year.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Other Fellowship Reporting
Requirements:

The fellowship award recipient has up to six months from the
issue date on the Notice of Award to activate the award using the Kirschstein-NRSA
Individual Fellowship Activation Notice (PHS 416-5).
Under unusual circumstances, NIH may grant an extension of the activation
period upon receipt of a specific request from the fellow. Such a request must
be countersigned by the sponsor and an authorized institutional official.

Individuals admitted to the United
States as Permanent Residents must submit notarized evidence of legal admission
prior to the award.

At the conclusion of a fellowship, the fellow must submit a
Termination Notice (PHS 416-7)
via xTrain to the NIH within 30 days of termination. Fellows with service payback
requirements must notify the NIH of any change in address and submit Annual
Payback Activities Certification Forms (PHS 6031-1)
until the payback service obligation is satisfied.

Section
VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Special Note: Applicants are cautioned that not all
NIH Institutes and Centers (ICs) participate in this program, and that
consultation with relevant IC staff prior to submission of an application is
strongly encouraged. The participating ICs have different emphases and program
requirements for this program. Therefore, a prospective applicant is urged to
consult the Table of IC-Specific
Information, Requirements and Staff Contacts to determine whether
the planned research and training falls within the mission of one of the
participating NIH ICs.